A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA

Part of paid clinical trials in Coronado, California.

Sponsor
Eli Lilly and Company
Study ID
NCT03742973
Phase
PHASE2
Status
Terminated

Conditions

  • Primary Biliary Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.

Study Details

This study evaluates the safety and efficacy of baricitinib in participants with primary biliary cholangitis (PBC) who do not respond or are unable to take ursodeoxycholic acid (UDCA).

Key Dates

Start date
Mar 28, 2019
Status verified
Oct 2019
Primary completion
Sep 26, 2019
Completion
Sep 26, 2019

Study Design

Enrollment
2 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib Cohort A
    Participants received 2 milligram (mg) of Baricitinib tablet orally once a day for 12 weeks. Cohort A is not reported due to protection of personal identifiable information based on enrollment futility.
  • Placebo Comparator: Placebo Cohort A
    Participants received placebo orally once a day for 12 weeks. Cohort A is not reported due to protection of personal identifiable information based on enrollment futility.
  • Experimental: Baricitinib Cohort B
    Participants received 4 mg of Baricitinib orally once a day for 12 weeks. Cohort B was planned, but due to enrollment futility, the strategic decision was made to terminate the study.
  • Placebo Comparator: Placebo Cohort B
    Placebo administered orally. Cohort B was planned, but due enrollment futility, the strategic decision was made to terminate the study.

Primary Outcome Measure

Change From Baseline in Alkaline Phosphatase (ALP) [ Time Frame: Baseline, Week 12 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Southern California GI and Liver Centers (SCLC)CoronadoCalifornia92118-
University of California, Davis - Health SystemsSacramentoCalifornia95817-
University of Colorado School of MedicineAuroraColorado80045-
Schiff Center for Liver Diseases/University of MiamiMiamiFlorida33136-
The Institute for Digestive Health and Liver Disease at MercyBaltimoreMaryland21202-
Henry Ford HospitalDetroitMichigan48202-
NYU LangoneNew YorkNew York10016-
UH Cleveland Medical CenterClevelandOhio44106-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Coronado, CA

By research site
Southern California GI and Liver Centers (SCLC)· Coronado, CAUniversity of California, Davis - Health Systems· Sacramento, CAUniversity of Colorado School of Medicine· Aurora, COSchiff Center for Liver Diseases/University of Miami· Miami, FLThe Institute for Digestive Health and Liver Disease at Mercy· Baltimore, MDHenry Ford Hospital· Detroit, MI

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